CAJ | 학술논문

生物制药创新面临巨大的风险,管理生物制药的创新风险必须从其创新特性入手。基于生物制药的接力创新模式,针对＂发现＂、＂大学-专家型公司＂接力＂、转化＂＂、专家型公司-核心公司＂接力＂、实现＂等主要环节归纳其典型创新风险,在此基础上引入＂中间风险＂的概念,并分析风险的关联和传导效应,进一步揭示生物制药创新风险的特性。最后针对政府主管部门的分析,提出管控生物制药安全风险的思路。
생물제약창신면림거대적풍험,관리생물제약적창신풍험필수종기창신특성입수。기우생물제약적접력창신모식,침대＂발현＂、＂대학-전가형공사＂접력＂、전화＂＂、전가형공사-핵심공사＂접력＂、실현＂등주요배절귀납기전형창신풍험,재차기출상인입＂중간풍험＂적개념,병분석풍험적관련화전도효응,진일보게시생물제약창신풍험적특성。최후침대정부주관부문적분석,제출관공생물제약안전풍험적사로。
The bio-pharmaceutical innovation has been confronted with huge risk, which must be managed from the aspects of innovation characteristics. Based on the relay innovation patterns in bio-pharmaceutical industries, the typical innovation risks in main steps are researched in sequence, proceeding from discovery, University-expert company relay, transformation, expert company-core company relay, to realization. On these bases, the concept of intermediate risk has been defined, and the relevancies and conductive effects among innovation risks are analyzed, which makes further efforts on revealing the characteristics of bio-pharmaceutical innovation risks. In the end, the specific thinking for the government drug safety risk management and control are presented.